With concern about drug counterfeiting and diversion rising, there is no doubt that pharmaceutical products will eventually be identified at the item level by a serialized code and that chain-of-custody, or pedigree, records documenting their travels through the supply chain will be required.
How and when this will be accomplished are far less certain. Although various digital coding systems currently on the market can apply serialized codes to primary packages at line speeds, radio frequency identification (RFID) is favored by the U.S. Food and Drug Administration (FDA) as the enabling technology for collecting the data that will enable product tracking and tracing and the creation of electronic 'e-pedigree' records, which can reveal unauthorized touch points.
Item-level tagging and supply chain visibility also hold the promise of significant cost savings for pharmaceutical companies "through better inventory management at all levels of the supply chain," noted Randall W. Lutter, Ph.D., associate commissioner for Policy and Planning at the Food and Drug Administration (FDA), during a keynote address at RFID World this past March.
However, the industry has been slow to adopt item-level RFID technology largely due to unresolved questions: Which frequency is best? What information should the serialized item-level code contain? What other data should the tag carry? How will data be collected, maintained, and accessed? And where will it reside?
The varying pedigree regulations taking effect and under consideration in multiple states and by the FDA have added another layer of uncertainty.
Nevertheless, for pharmaceutical manufacturers, "Item-level tagging is not a question of if, but when," says Bill Allen, director of strategic alliances and programs at Texas Instruments Inc. (Plano, TX).
And progress has been made. Two working groups recently formed by EPCglobal Inc. (Brussels, Belgium) have been tasked with answering the need for standards. The mission of the UHF (ultra high frequency) Air Interface Working Group is to develop extensions to the current Gen 2 UHF protocol for security features needed for item-level tagging.
The HF (high frequency) Air Interface Working Group's charge is to extend the logic and technology of today's UHF Gen 2 standard into the 13.56 MHz band. "High frequency performs well in certain pharmaceutical applications, so it makes sense to extend the global reach of Gen 2 to HF," says Mike Rose, vice president of RFID/EPC at Johnson & Johnson (New Brunswick, NJ), who co-chairs EPCglobal's Healthcare and Life Sciences Business Action Group and also serves on EPCglobal's Board of Governors.
The FDA also wants to accelerate adoption of RFID technology, which agency officials had expected to be well established by 2007, and has reconvened its Counterfeit Task Force to assess progress, identify obstacles delaying adoption for tracking and tracing product, and recommend ways to overcome these hurdles.
Entering the Fray